As this issue goes to press, molnupiravir is dominating the news cycle, spreading hope that an authorization from the FDA and other regulators around the world could help change the course of the pandemic once and for all.
Molnupiravir is an experimental oral antiviral medication developed at Emory University by the university’s drug innovation company, Drug Innovation Ventures at Emory (DRIVE). It was then acquired by Miami-based Ridgeback Biotherapeutics, who later partnered with Merck to develop the drug further.

Interim data from phase 3 trials showed molnupiravir cut the risk of hospitalization or death in fifty percent of people with mild to moderate COVID-19. Merck said the efficacy of molnurapiravir was so compelling that clinicians stopped enrollment early in consultation with the FDA.

The experimental pill reduced the risk of hospitalization or death across all key subgroups and the efficacy was not affected by the timing of symptom onset or underlying risk factors. On top of it, the yet-to-be-approved drug demonstrated consistent efficacy across SARS-CoV-2 variants Gamma, Delta and Mu.

Anticipating a green light from regulators, pharma manufacturers have already begun to mobilize.

In “A Pill for the Pandemic,” Contract Pharma contributor Harachand reports from India that the race to make molnupiravir is heating up among antiviral manufacturers there.

As of printing, Merck has signed eight deals to sell more than a total of 2 million doses of the pill to governments around the world as countries scramble to tame the virus. If granted approval in the U.S., Merck said it can make 10 million doses in 2021.

The drug maker also reached a deal with the United Nations-backed Medicines Patent Pool that will allow more companies to manufacture generic versions of the pill with a royalty-free license applying to 105 low- and middle-income countries. So far Merck has agreed to license the drug to several India-based generic drug makers.

In his article on page 28, Harachand reports that Merck has struck voluntary licensing deals with at least eight Indian manufacturers to make the low-cost versions of the investigational antiviral.

“In another unprecedented move,” he writes, “five of Merck’s partnering firms—Cipla, Sun Pharma, Dr. Reddy’s Lab, Emcure Pharma and Torrent Pharmaceuticals—have reached an agreement to join hands for clinical trials using molnupiravir on Indian patients.”

However, while initial data seems to support Merck’s and Ridgeback’s claim that the drug’s antiviral effects are powerfully effective against SARS-CoV-2, the potential trouble with the drug is that it may also create havoc in our own healthy DNA, according to William A. Haseltine, reporting for Forbes.com in his article, “Harming Those Who Receive It: The Dangers Of Molnupiravir (Part 2).”

He says researchers have been trying as far back as 1980 to understand how damaging NHC, molnupiravir’s metabolite, can be to healthy cells and that overexposure could potentially lead to long-term illness like cancer.
When asked by reporters about potential negative effects, Merck has answered by saying that, “the drug will be safe if used as intended and at the concentrations where we have looked and in the concentrations which we are achieving in patients.”

Tim Wright, Editor
twright@rodmanmedia.com